CN110325231B - Device and method for injecting a drug - Google Patents

Device and method for injecting a drug Download PDF

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Publication number
CN110325231B
CN110325231B CN201780084896.8A CN201780084896A CN110325231B CN 110325231 B CN110325231 B CN 110325231B CN 201780084896 A CN201780084896 A CN 201780084896A CN 110325231 B CN110325231 B CN 110325231B
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CN
China
Prior art keywords
sleeve
syringe
barrel
configuration
needle
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
CN201780084896.8A
Other languages
Chinese (zh)
Other versions
CN110325231A (en
Inventor
T·R·哈尔塞特
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Action Medical Technologies LLC
Original Assignee
Action Medical Technologies LLC
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority to US201662439206P priority Critical
Priority to US62/439,206 priority
Priority to US201762478708P priority
Priority to US62/478,708 priority
Application filed by Action Medical Technologies LLC filed Critical Action Medical Technologies LLC
Priority to PCT/US2017/066957 priority patent/WO2018125629A1/en
Publication of CN110325231A publication Critical patent/CN110325231A/en
Application granted granted Critical
Publication of CN110325231B publication Critical patent/CN110325231B/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/3129Syringe barrels
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M11/00Sprayers or atomisers specially adapted for therapeutic purposes
    • A61M11/006Sprayers or atomisers specially adapted for therapeutic purposes operated by applying mechanical pressure to the liquid to be sprayed or atomised
    • A61M11/007Syringe-type or piston-type sprayers or atomisers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/20Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/28Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
    • A61M5/281Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle using emptying means to expel or eject media, e.g. pistons, deformation of the ampoule, or telescoping of the ampoule
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31565Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/31576Constructional features or modes of drive mechanisms for piston rods
    • A61M5/31578Constructional features or modes of drive mechanisms for piston rods based on axial translation, i.e. components directly operatively associated and axially moved with plunger rod
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321Means for protection against accidental injuries by used needles
    • A61M5/3213Caps placed axially onto the needle, e.g. equipped with finger protection guards
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321Means for protection against accidental injuries by used needles
    • A61M5/322Retractable needles, i.e. disconnected from and withdrawn into the syringe barrel by the piston
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321Means for protection against accidental injuries by used needles
    • A61M5/3243Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321Means for protection against accidental injuries by used needles
    • A61M5/3243Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/326Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321Means for protection against accidental injuries by used needles
    • A61M5/3243Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/3271Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel with guiding tracks for controlled sliding of needle protective sleeve from needle exposing to needle covering position
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00Inhalators
    • A61M15/08Inhaling devices inserted into the nose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/20Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M2005/2006Having specific accessories
    • A61M2005/2013Having specific accessories triggering of discharging means by contact of injector with patient body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/20Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M2005/2073Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically preventing premature release, e.g. by making use of a safety lock
    • A61M2005/208Release is possible only when device is pushed against the skin, e.g. using a trigger which is blocked or inactive when the device is not pushed against the skin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321Means for protection against accidental injuries by used needles
    • A61M5/3243Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/3245Constructional features thereof, e.g. to improve manipulation or functioning
    • A61M2005/3247Means to impede repositioning of protection sleeve from needle covering to needle uncovering position
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321Means for protection against accidental injuries by used needles
    • A61M5/3243Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/326Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user
    • A61M2005/3267Biased sleeves where the needle is uncovered by insertion of the needle into a patient's body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/58Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/581Means for facilitating use, e.g. by people with impaired vision by audible feedback
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/58Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/582Means for facilitating use, e.g. by people with impaired vision by tactile feedback
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31511Piston or piston-rod constructions, e.g. connection of piston with piston-rod
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3202Devices for protection of the needle before use, e.g. caps

Abstract

A syringe for delivering a medicament includes an outer sleeve, an inner sleeve, and a barrel. The inner sleeve portion is disposed within the outer sleeve. The plunger rod of the barrel is engaged with the outer sleeve in a fixed spatial relationship such that the plunger rod translates with the outer sleeve as a unit. The outer sleeve is configured to translate axially relative to the inner sleeve from a first configuration in which the inner sleeve extends a first distance from the outer sleeve to a second configuration in which the inner sleeve extends a second distance from the outer sleeve that is less than the first distance. Additionally, in a third configuration, the inner sleeve extends from the outer sleeve a third distance greater than the second distance and limits axial translation of the inner sleeve relative to the outer sleeve.

Description

Device and method for injecting a drug
Cross Reference to Related Applications
Priority of the present application claims priority of united states provisional application No. 62/478,708 filed on 30/3/2017 and united states provisional application No. 62/439,206 filed on 27/12/2016, the entire contents of which are incorporated herein by reference.
Technical Field
The present invention relates to a syringe for medication. And in particular to injectors configured to inject medication from a syringe.
Background
Many methods are used to inject drugs to a target site. These include syringes, autoinjectors and drug pumps. The drug may be injected at different depths. For example, the drug may be injected into the epidermis, dermis, subcutaneous region, or muscle (intramuscularly). Some of these devices are dedicated to home use by the patient. These devices can be used to deliver a variety of drugs. For example, the syringe may be used to deliver epinephrine to a patient at risk of an allergic reaction. Such devices include ANAPEN sold by Lincoln Medical Ltd, ukTMSyringes and syringes sold by Milan corporation of Pennsylvania (Mylan Inc.)A syringe.
Many syringes use a powerful spring to drive a plunger rod into a pre-filled syringe and inject the medication into the tissue while pushing the syringe to one side of the leg or other body part. Some of these syringes have the advantage of shielding the needle before and after use, thereby benefiting patients who are afraid of needles. Syringes currently contain more than twenty-six parts and are complicated to assemble due to the large number of parts and complexity, which can result in high prices for the user. The additional parts also increase the likelihood of failure of these complex devices.
Disclosure of Invention
In one embodiment, a syringe for delivering a medicament includes an outer sleeve, an inner sleeve, and a barrel. The outer sleeve defines a longitudinal axis. The inner sleeve portion is disposed within the outer sleeve. The barrel has a barrel, a needle mounted to a distal end of the barrel, a plunger rod, and a seal slidably mounted in the barrel. The plunger rod is engaged with the outer sleeve in a fixed spatial relationship such that the plunger rod and the outer sleeve translate as a unit throughout operation of the syringe. The outer sleeve is disposed and configured to translate axially relative to the inner sleeve from a first configuration in which the inner sleeve extends a first distance from the outer sleeve to a second configuration in which the inner sleeve extends a second distance from the outer sleeve that is less than the first distance. Additionally, in a third configuration, the inner sleeve extends from the outer sleeve a third distance greater than the second distance and limits axial translation of the inner sleeve relative to the outer sleeve.
In another embodiment, a syringe for delivering a medicament includes an outer sleeve, an inner sleeve, and a barrel. The inner sleeve portion is disposed within the outer sleeve. The inner sleeve defines a chamber between distal and proximal ends of the inner sleeve and has an engagement member extending into the chamber at a location between the distal and proximal ends. The barrel has a barrel, a needle mounted to a distal end of the barrel, a plunger rod, and a seal slidably mounted in the barrel. The plunger rod is engaged with the outer sleeve in a fixed spatial relationship such that the plunger rod and the outer sleeve translate as a unit throughout operation of the syringe. The outer sleeve is disposed and configured to axially translate relative to the inner sleeve, and in a first configuration, the engagement member is spaced apart from the barrel of the syringe. In a second configuration, the barrel contacts the engagement component such that continued axial translation of the outer sleeve causes translation of the plunger rod relative to the barrel to deliver the medicament through the needle.
In another embodiment, a method for operating a syringe to deliver a drug to a target location includes the step of placing a distal end of an inner sleeve against the target location. The method also includes the step of applying a force to the outer sleeve. Applying the force to the outer sleeve causes axial translation of the outer sleeve and barrel relative to the inner sleeve. Applying the force also causes a needle of the barrel to extend out of the distal end of the inner sleeve and into the targeted location. The force also causes the syringe to contact the engagement means of the inner sleeve. The method also includes the step of applying a continuous force to the outer sleeve. Applying the continuous force to the outer sleeve causes translation of the plunger rod and seal within the barrel, thereby delivering the medicament. The method also includes the step of removing the syringe from the target site. Upon removal, a biasing means exerts a force on the inner sleeve to translate the inner sleeve relative to the outer sleeve in the distal direction to cover the needle of the syringe such that the inner sleeve is locked in place relative to the outer sleeve.
Drawings
These and other features of the apparatus and methods provided herein will be more fully disclosed in or made apparent from the following detailed description of the preferred embodiments of the invention, which is to be considered together with the accompanying drawings, in which like numerals refer to like parts, and further wherein:
FIG. 1 is an isometric view of one embodiment of a syringe for medication;
FIG. 1A is a cross-sectional view of the syringe of FIG. 1;
FIG. 1B is an isometric view of the embodiment of FIG. 1 with the cover removed;
FIG. 2 is an exploded view of the syringe of FIG. 1;
FIG. 2A is a cross-sectional view of the cap;
FIG. 3 is an isometric view of the outer sleeve;
FIG. 4 is an isometric view of the inner sleeve;
FIG. 5A is a cross-sectional view of the syringe of FIG. 1 in an initial configuration;
FIG. 5B is a detail view of the flexible arm and raised edging in the initial configuration;
fig. 6A is a cross-sectional view of the syringe of fig. 1 in a second configuration;
fig. 6B is an isometric view of the syringe of fig. 1 in a second configuration;
FIG. 6C is a detail view of the flexible arm and raised edging in a second configuration;
fig. 7A is a cross-sectional view of the syringe of fig. 1 in a third configuration;
fig. 7B is an isometric view of the syringe of fig. 1 in a third configuration;
FIG. 7C is a detail view of the flexible arms and raised edging before the delivery of the medicament is complete;
FIG. 7D is a detail view of the flexible arms and raised rim after delivery of the drug is complete;
fig. 8A is a cross-sectional view of the syringe of fig. 1 in a fourth configuration;
fig. 8B is an isometric view of the syringe of fig. 1 in a fourth configuration;
FIG. 8C is a detail view of the flexible arm and raised edging in a fourth configuration;
FIG. 9 is an isometric view of another embodiment of a syringe;
FIG. 10 is an exploded view of the syringe of FIG. 9;
FIG. 11 is an isometric view of the syringe of FIG. 9 prior to assembly of the cap onto the syringe;
FIG. 12 is an isometric view of the syringe of FIG. 9 after removal of the cap and needle cover from the syringe;
FIG. 13 is an isometric view of the syringe of FIG. 9 after use;
FIG. 14A is an isometric view of the injector and nozzle;
FIG. 14B is a side view of the syringe and nozzle of FIG. 14A in an assembled configuration;
FIG. 14C is an isometric view of the syringe and nozzle of FIG. 14A during use;
FIG. 14D is a cross-sectional view of the syringe and nozzle of FIG. 14A in a first configuration;
FIG. 14E is a cross-sectional view of the syringe and nozzle of FIG. 14A in a second configuration;
fig. 15 is an isometric view of a syringe having a luer connector and tubing set;
fig. 16 is an isometric view of a syringe having a handle.
Detailed Description
Such description of the preferred embodiments is intended to be understood in connection with the accompanying drawings, which are to be considered part of the entire written description of this invention. The drawings, which are not necessarily to scale, and certain features of the invention may be shown exaggerated in scale or in somewhat schematic form in the interest of clarity and conciseness. In the description, relative terms such as "horizontal," "vertical," "upper," "lower," "top" and "bottom" as well as derivatives thereof (e.g., "horizontally," "downwardly," "upwardly," etc.) should be construed to refer to the orientation as then described or as shown in the drawing figures in the discussion. These relative terms are for convenience of description and generally are not intended to require a particular orientation. Terms including "inwardly" versus "outwardly," "longitudinal" versus "lateral," and the like, should be interpreted relative to each other or relative to an axis of elongation or rotation or center of rotation, as appropriate. Terms concerning attachments, coupling and the like (e.g., "connected" and "interconnected") refer to a relationship wherein structures are secured or attached to one another either directly or indirectly through intervening structures, as well as both movable or rigid attachments or relationships, unless expressly described otherwise. The term "operatively or operatively connected" is such attachment, coupling or connection that allows the pertinent structures to operate as intended by virtue of that relationship. In the claims, means-plus-function clauses, if used, are intended to cover the structures described, suggested, or rendered obvious by the written description or drawings for performing the recited function, including not only structural equivalents but also equivalent structures. The term "drug" or "drug" as used herein refers to any substance for delivery to a target. For example, these terms include anticoagulants, vaccines, biologics, and any injectable fluid.
The present disclosure provides an injector for injecting a drug into a target site. The syringe provides easy use by a patient or other caregiver and is configured for reliable use after storage for a long period of time. Furthermore, because the syringe utilizes a small number of parts, it is inexpensive and easy to manufacture. The syringes described herein can be used to deliver, for example, epinephrine, ketamine, moxifloxacin, ertapenem, atropine, diazepam, or naloxone.
Fig. 1 shows an isometric view of the syringe 100 in a factory configuration. Syringe 100 comprises a body 102 and a cap 103. With the cap 103 engaged with the body 102, it is not possible to manipulate the syringe 100 to dispense the contents of the syringe 100. The syringe may also include a label 101. The label 101 may surround at least a portion of the body 102 and the cover 103 to prevent inadvertent removal of the cover 103. Furthermore, this arrangement of the body 102, cap 103 and label 101 may maintain sterility of the syringe contained within the syringe 100. The label may contain a perforated portion 101a which allows tearing of the label 101 and removal of the lid 103. The perforations may be positioned generally at the proximal end of the lid 103, thereby allowing the label 101 to be torn and the lid 103 to be removed. The label 101 may be torn at the perforation, as shown in fig. 1B, by rotation of the lid 103 relative to the body 102, for example. In some embodiments, the perforations do not penetrate sufficiently through the label 101 (i.e., the perforations only partially penetrate the label). In this embodiment, by enclosing the body 102 and the cap 103 with the label 101, the flow of material into the syringe 100 is restricted. For example, the label 101 may provide a water-resistant property that prevents water from entering the syringe. This advantageously protects the contents of syringe 100.
As can be seen in the exploded view of fig. 2, the body 102 includes an outer sleeve 104 and an inner sleeve 106. A syringe 108 is disposed within the body 102. The outer sleeve 104 defines a longitudinal axis a. When assembled, the inner sleeve 106 is disposed partially within the outer sleeve 104. In the illustrated embodiment, the outer sleeve 104 and the inner sleeve 106 are generally cylindrical in shape. However, the outer sleeve 104 and the inner sleeve 106 may have any suitable shape, with the shapes selected to provide a desired appearance.
The syringe 108 is prefilled with a medicament and includes a barrel 110, a needle 112 (shown in fig. 5A), a needle cover 113, a seal 114, and a plunger rod 116. The syringe 108 is pre-filled with a drug. The cylinder 110 may be a glass cylinder, for example, a glass cylinder constructed from a straight glass rod. Alternatively, the barrel 110 may be constructed of a polymeric material. The cartridge 110 may be coated with a material to reduce chemical interaction between the cartridge 110 and the drug. A needle 112 is mounted at the distal end of the barrel 110 and defines a lumen through which drug may be delivered from the barrel 110 to a target site. Needle 112 may be attached to barrel 110 using any suitable method, such as post support and adhesive. The seal 114 is disposed within the barrel 110 and is configured for axial translation within the barrel 110. The seal 114 may be constructed of an elastomeric material and provides a seal against the inner wall of the barrel 110 to maintain sterility of the drug prior to use. Plunger rod 116 is engaged with the seal and includes an elongated portion extending from the proximal end of barrel 110 and cap 116 a.
In the factory configuration as shown in fig. 1A, the cap 103 engages the needle cover 113. Thus, removal of the cap 103 from the body removes the needle cap 113 from the barrel. As shown in fig. 2A, the cap 103 includes a protrusion 103a that engages the distal end of the needle cover 113. The needle cover 113 may include a flange 113a adjacent its distal end. Protrusion 103a may include teeth 103b configured to engage flange 113 a. Thus, when the cap 103 is removed, the needle cover 113 is also removed. The protrusion 103a passes through an aperture at the distal end of the inner sleeve 106 to provide access to the needle cover 113.
Rotation of the cap 103 relative to the body 102 during removal may also cause rotation of the needle cap 113 relative to the barrel 108. This rotation may assist in overcoming any sticking of the needle cover 113 to the barrel 108, thereby making removal of the cap 103 and needle cover 113 easier for the user.
The syringe 100 may also include a biasing member 117. The biasing member may be disposed at least partially proximally of the inner sleeve 106 and bias the inner sleeve 106 to an extended position, as shown in figure 5A. The distal end of the biasing member 117 may be in contact with the inner sleeve 106 and the proximal end of the biasing member 117 may be in contact with the plunger rod 116 or the outer sleeve 104. The biasing member 117 may be any suitable member capable of storing and releasing energy. For example, the biasing member 117 may be a spring (e.g., a coil spring or a helical spring), an elastomeric sleeve, or a flexible arm extending from the outer sleeve 104. As will be described further herein, the biasing means 117 maintains the inner sleeve 106 in an extended position prior to insertion of the needle to the target point, and also extends the inner sleeve 106 after removal of the syringe 100 from the target location. The stiffness of the biasing member 117 may be significantly lower than that used in other syringes. For example, in one embodiment, the biasing member 117 is a compression spring having a spring rate between about 0.50 and 0.60 lbs/inch. In another embodiment, the spring rate is between about 0.25 and 0.75 lbs/inch. In another embodiment, the spring rate is between about 0.10 and 0.50 lbs/inch. Using a biasing member having a lower stiffness than other syringes, the cost of the biasing member itself is reduced. Furthermore, the cost of other parts of the syringe may be lower as it does not need to be configured to withstand higher forces.
As shown in fig. 3, the outer sleeve 104 has a generally cylindrical sidewall 118 defining a proximal end 120 and a distal end 122. As shown, the outer sleeve may be constructed in a clamshell type arrangement, with the first portion 121 connected to the second portion 123 by a living hinge. During assembly, the first and second portions 121, 123 are brought together to fixedly close the outer sleeve 104. Alternatively, the first portion 121 and the second portion 123 may be separate components (i.e., not connected by a living hinge). In this embodiment, the separate first and second portions 121, 123 are brought together during assembly. The outer sleeve 104 may include features to hold the first portion 121 and the second portion 123 in a fixed relationship for storage and use. For example, one of the first portion 121 or the second portion 123 may have a flexible arm configured to engage a dimple or cavity on the opposing portion. Alternatively, the first portion 121 and the second portion 123 may be connected using a hot melt column process, wherein a stud on one of the first portion 121 and the second portion 123 expands using heat to fill a hole of the opposite portion. Alternatively, the first portion 121 and the second portion 123 may be welded to each other using ultrasonic welding or another process.
Further, during assembly, the plunger rod 116 is engaged with the outer sleeve 104, e.g., at the proximal end 120. Thus, plunger rod 116 is in a fixed spatial relationship with outer sleeve 104 such that plunger rod 116 and outer sleeve 104 translate as a unit throughout the operation of syringe 100. In one embodiment, sidewall 118 defines a keyway 124, and plunger rod 116 includes a corresponding key 125. During assembly, the key 125 is disposed in the keyway 124 to prevent relative movement between the plunger rod 116 and the outer sleeve 104. Alternatively, plunger rod 116 may be engaged with outer sleeve 104 using any suitable method, including a press-fit interface, a plunger rod to outer sleeve bond, a threaded engagement, or a pin connecting the plunger rod to the outer sleeve.
The outer sleeve 104 also includes a raised border 126, as best shown in FIG. 3. Raised edging 126 extends from sidewall 118. The raised edging 126 extends along a path having a longitudinal component parallel to the longitudinal axis a and a circumferential component extending along the circumference of the outer sleeve 104. In some embodiments, raised edging 126 is disposed within a recess 128 in sidewall 118. The notches 128 allow the raised border 126 to interface with the inner sleeve 106 without imparting an inward radial force on the inner sleeve 106. In addition, notch 128 defines an impact surface 129 at the proximal end of raised edging 126. In at least one embodiment, the outer sleeve 104 includes at least two raised edging 126. In the illustrated embodiment, the outer sleeve includes two raised edging 126 positioned 180 ° from one another (directly opposite one another). This creates a balancing force on the inner and outer sleeves.
The inner sleeve 106 may also be provided in a clamshell configuration, as described above with reference to the outer sleeve 104. As shown in fig. 4, the inner sleeve 106 includes a sidewall 130 defining a proximal end 132 and a distal end 134. As described above, the biasing member 117 may contact the proximal end 132 to bias the inner sleeve 106 to the extended position. The inner sleeve 106 also includes one or more engagement members 135 that extend into a cavity defined within the sidewall 130 between the proximal end 132 and the distal end 134. As will be described in greater detail below, the engagement component 135 is configured to contact the syringe 108 during operation to limit the insertion depth of the needle 112 into the targeted location. In the illustrated embodiment, the engagement member 135 is spaced from the distal end 134. The distance that engagement member 135 is spaced from distal end 134 defines the insertion depth of needle 112. Thus, the insertion depth can be accurately controlled during manufacture of the inner sleeve 106. Appropriate tolerances may be applied to the distance between the engagement member 135 and the distal end 134 of the inner sleeve 106 to ensure that the injection reaches the desired location in the tissue. For example, in one embodiment, the needle 112 extends approximately 16mm (0.62 inches) from the distal end of the inner sleeve 106. In another embodiment, the needle 112 extends approximately 25mm (1.0 inch) from the distal end of the inner sleeve 106. In another embodiment, the needle 112 extends approximately 38mm (1.5 inches) from the distal end of the inner sleeve 106. The engagement member 135 may be integrally formed with the inner sleeve 106, or alternatively, may be a separate component assembled to the inner sleeve 106.
As shown in fig. 4, the inner sleeve 106 also includes flexible arms 136. The flexible arms 136 extend generally parallel to the longitudinal axis a and include protrusions 138 that extend radially outward toward the outer sleeve 104. Protrusion 138 interfaces with raised edging 126 during operation of syringe 100, as will be described further below. In the illustrated embodiment, the inner sleeve 106 includes two flexible arms 136 positioned 180 ° from each other (directly opposite each other). This ensures that the forces applied to the inner sleeve 106 are balanced, as described above.
Fig. 5A-8C show views of steps of operation of the syringe 100. Prior to use, the cap 103 is removed from the syringe 100. Because the cap 103 is engaged with the needle cover 113, removal of the cap 103 will cause the needle cover 113 to be removed from the barrel 108. The cap and needle cover can now be discarded. Subsequently, as shown in fig. 5A, the distal end 134 of the inner sleeve 106 is placed against the target location. As seen in fig. 5A, in this configuration, the inner sleeve 106 extends a first distance from the outer sleeve 104 and covers the needle 112. Additionally, in this configuration, the biasing member 117 is in a relatively de-energized state. In this de-energized state, biasing member 117 does not apply significant force to the components of syringe 100. This allows syringe 100 to be stored for extended periods of time without risk of damage to the components therein.
As shown in fig. 5B, in this initial configuration, projection 138 of flexible arm 136 is initially positioned at the distal end of raised edging 126. The protrusions are positioned on a first side of raised edging 126. In this configuration, flexible arm 136 is in an unstressed state (i.e., in this configuration, the interaction of protrusion 138 with raised edging 126 does not cause deflection of the flexible arm). This ensures that these parts do not creep or exhibit permanent deformation during storage. This allows the device to be stored for extended periods without the risk of damaging the components, thereby increasing the reliability of the syringe.
As illustrated in fig. 6A, a force applied to the outer sleeve in the distal direction moves the outer sleeve 104 toward the target location and, thus, reduces the extension of the inner sleeve from the outer sleeve to the second distance. This can also be seen in the isometric view of fig. 6B. Because the plunger rod 116 is engaged with the outer sleeve 104, the plunger rod 116 translates with the outer sleeve 104. Plunger rod 116 causes movement of seal 114 and, because seal 114 is in sealing engagement with barrel 110, the static friction between seal 114 and barrel 110 causes movement of barrel 108. The syringe 108 translates in the distal direction with the outer sleeve 104 until the syringe 108 contacts the engagement assembly 135. This translation of the syringe 108 causes the needle 112 to be inserted into the targeted location. The engagement elements 135 may contact the barrel 110 of the syringe or a crimped cap or other component engaged with the barrel 110. At this point, shown in fig. 6A and 6B, continued translation of the syringe barrel 110 is restricted.
Translation from the configuration shown in fig. 5A to the configuration shown in fig. 6A causes the biasing member to be compressed or de-energized, thereby storing energy for later release.
As shown in figure 6C, as the outer sleeve 104 translates from the first configuration to the second configuration relative to the inner sleeve 106, the projection 138 of the flexible arm 136 travels along the first side 126a of the raised edging 126. In doing so, the flexible arm 136 deflects from its unstressed, natural position to the deflected position shown in fig. 6C.
Continued displacement of the outer sleeve 104 causes injection of the medicament, as shown in fig. 7A. As shown in fig. 7A and 7B, the extension of the inner sleeve 106 from the outer sleeve 104 is further reduced. Because syringe barrel 110 is restricted from further movement by contact with engagement element 135, continued displacement of outer sleeve 104 and plunger rod 116 translates seal 114 within barrel 110 of syringe 108. This causes the drug to be expelled from the barrel 110, through the needle 112, and into the target site. In addition, the biasing member 117 is further compressed or energized.
This continued translation of the outer sleeve 104 brings the projection 138 to the proximal end of the raised edging, as shown in fig. 7C. As shown in the transition from fig. 7C to fig. 7D, upon completion of expelling the medicament, the protrusion 138 disengages from the first side 126a of the raised edging 126. When the protrusion disengages, the elastic energy stored in the flexible arm 136 returns the flexible arm 136 toward its natural position. In doing so, the protrusion 138 or another portion of the flexible arm 136 contacts the strike face 129 on the outer sleeve 104. Contact with the strike face 129 provides audible and/or tactile feedback to the user that delivery of the medicament is complete.
As shown in fig. 8A-8C, upon completion of the injection and removal of the syringe 100 from the target site, the biasing member 117 is de-energized and translates the inner sleeve 106 in a distal direction relative to the outer sleeve 104 such that the inner sleeve 106 extends a third distance from the outer sleeve 104. The third distance may be the same as the first distance, or alternatively, may be different. When the inner sleeve 106 is extended, it covers the needle 112. Thus, the needle 112 is covered before and after use of the syringe 100. This protects against needle stick injuries and hides the needle from view, which is particularly important for patients who are afraid of needles.
As inner sleeve 106 extends, tab 138 travels along second side 126b of raised edging 126. Upon sufficient extension of inner sleeve 106, protrusion 138 snaps into cavity 127 formed between the proximal end of raised edging 126 and locking feature 139. In this position, the protrusion prevents translation of the inner sleeve 106 in the proximal or distal direction. Thus, the inner sleeve is locked in place and cannot translate to expose needle 112. In at least one embodiment, the flexible arms 136 are in a stressed or deformed position when the protrusions are disposed in the cavities 127. As a result, the internal force in flexible arms 136 pushes tabs 138 into the ends of raised edging 126 to further prevent retraction of inner sleeve 106.
In one embodiment, the protrusion 138 has an "L" shaped cross-section. As a result, a notch is formed that engages the end of raised edging 126 to lock flexible arm 136 in place.
In other embodiments, as shown in fig. 9-13, a syringe with a retractable needle is used. However, a repeated description is not included herein, and this embodiment may include many of the same features, aspects, and configurations described above with respect to the embodiment of fig. 1-8C. In this embodiment, after the injection is complete, the needle of the syringe is configured to retract into the barrel of the syringe. One example of such a syringe is sold by Becton-dikinson (Becton Dickinson) of new jerseyHowever, any retractable syringe may be used. The syringe may be pre-filled, or alternatively, filled at the time of use by removing the medicament from the vial. In the case of filling at the time of use, a bottle adapter can be used.
The syringe 200 of fig. 9 to 12 comprises a body 202 and a cap 203. The body 202 includes an outer sleeve 204 and an inner sleeve 206 and a needle sleeve 207. The needle sleeve 207 is configured for axial translation within the inner sleeve 206 and relative to the inner sleeve 206. The inner sleeve 206 is configured for axial translation within the outer sleeve 204 and relative to the outer sleeve 204. As shown in fig. 10, the syringe 208 is inserted into the body 202 such that the needle 212 of the syringe extends from the distal end of the inner sleeve 206. After placing syringe 208 within body 202, outer sleeve 204 may be closed.
In this embodiment, the barrel 210 of the syringe is in a fixed position relative to the inner sleeve 206. The flange 210a of the barrel 210 may be positioned within the slot 240 of the inner sleeve 206 to hold the barrel 210 in place. The flange 210a may be integrally formed with the barrel 210 or, alternatively, may be a separate component secured to the barrel 210 by bonding or other procedures. In certain embodiments, the inner sleeve 206 includes more than one slot, each slot corresponding to a different dose volume. For example, one slot may correspond to a dose volume of 0.3mg and a second slot may correspond to a dose volume of 0.15 mg. In this embodiment, the slots are at different distances from the proximal end of the outer sleeve 204, which results in the delivery of different dose volumes. The needle 212 extends at least partially from the distal end of the inner sleeve 206 by a flange 210a that is seated in a slot 240. This allows the cap 203 to engage the needle cover 213.
As shown in fig. 11, the cover 203 includes features for engaging the needle cover 213 of the syringe 208. In one embodiment, the lid 203 is a clamshell design having a living hinge 242 connecting an upper portion 244 and a lower portion 246. The lower portion 246 includes a protrusion 248 and the upper portion 244 includes an inner wall 250. During assembly, the cover 203 is closed around the needle cover 213 and connected to the body 202. When the cover 203 is closed, the protrusion 248 and the inner wall 250 engage the needle cover 213. As a result, after the cover 203 is removed from the body 202, the needle cover 213 is removed from the syringe 208, as illustrated in fig. 12.
When the cap 203 is removed from the syringe 200, the needle sleeve 207 translates in a distal direction relative to the inner sleeve 206. This may be caused by contact between the needle cover 213 and the needle hub 207. For example, the flange 213a (shown in fig. 10) of the needle cover 213 may contact the needle sleeve 207 and pull out the needle sleeve 207 when the needle cover 213 is removed. As a result, the needle sleeve 207 covers the needle 212 and prevents accidental needle sticks. The needle sleeve 207 may provide a visual indicator (e.g., a contrasting color) to alert the user that the syringe has not been used and the needle contained therein.
During insertion, the needle sleeve 207 is translatable in a proximal direction relative to the inner sleeve 206 to expose the needle 212 for insertion into a target site. Continued force applied to outer sleeve 204 causes injection of the medicament as described above.
Upon completion of the injection, the needle 212 of the syringe 208 is retracted into the barrel 210 of the syringe 208. This embodiment does not require biasing means to cause translation of the inner sleeve 206 relative to the outer sleeve 204 in the distal direction after injection. Because the needle 212 is safely enclosed in the barrel, needle stick injuries are prevented and the needle 212 is not visible to the user. The syringe 200 is compacted after use and occupies less space when discarded, as shown in fig. 13. Optionally, the syringe 208 may be removed from the injector 200 and discarded in a sharps container. In certain embodiments, the injector 200 may then be reused for a subsequent injection with another syringe.
In another embodiment, as shown in fig. 14A-14E, a nozzle 300 is provided. The nozzle 300 may be attached to the syringe 100 or the syringe 200. The nozzle 300 includes a body 302 and a tip 304 disposed at a distal end of the body 302. The nozzle 300 may also include one or more finger flanges 306, which may be located at the proximal end of the body 302. The tip 304 includes one or more holes 308 at its distal end through which the drug may exit.
The nozzle 300 allows for intranasal delivery of the drug, which avoids the need to insert a needle into the patient, which may be preferable for some patients (particularly patients who are afraid of needles). The syringe with nozzle 300 delivers an effective dose delivery by transmucosal delivery of the drug and blood flow to the patient. This may be particularly useful for drugs used to treat opioid overdose (e.g., naloxone).
The nozzle 300 is engaged with a syringe such that a needle is disposed in the distal end of the nozzle 300. After the medicament is dispensed through the needle by translating the outer sleeve relative to the inner sleeve, the medicament is compressed into a spray that can be delivered into the patient. By providing the nozzle 300, the drug may be delivered to the mucosa via the nozzle, or alternatively, intramuscularly, subcutaneously, via a needle, or at any other suitable depth. This provides the user or patient with a choice at the time of delivery, allowing them to choose a delivery method that is more comfortable or effective for them. In certain embodiments, the nozzle 300 and the syringe 100 or 200 are provided in a kit, e.g., in a common package.
In use, the cap 103 is first removed from the body 102 of the syringe 100 or 200. The nozzle 300 is placed on the body 102 such that the inner sleeve 106 or 206 abuts the distal end of the body 302 of the nozzle 300, as best shown in fig. 14D. The distal ends of the inner sleeves 106, 206 contact a shoulder 310 in the nozzle 300. The tip 304 of the nozzle 300 is positioned adjacent to or at least partially within the patient's nares. A force is then applied to the outer sleeve 104 or 204 to axially translate it relative to the inner sleeve 106 or 206 and the nozzle 300. This translation first translates the syringe 108 or 208 to a position where the needle 112 or 212 is at least partially within the tip 304 of the nozzle 300. Further translation of the outer sleeve 104 or 204 causes dispensing of the medicament, as described above and shown in fig. 14C. When operating the syringe, the user may hold the finger flange 306 of the nozzle 300 to provide a reactive force.
In one embodiment, as shown in fig. 14D and 14E, a baffle 312 is disposed within the tip 304 of the nozzle 300. In some embodiments, the septum 312 maintains sterility of the interior of the tip 304 prior to use. The depression of the outer sleeve 104 relative to the inner sleeve 106 causes the needle 112 to extend out of the inner sleeve 106 and puncture the septum 312. The septum 312 may be constructed from a material comprising an elastomer, silicone, or any other suitable material. Upon further translation of the outer sleeve 104, 204 towards the tip 304, the medicament is expelled. The septum 312 prevents the drug from traveling in a proximal direction out of the tip 304. As a result, the contents of the syringe are discharged through the one or more apertures 308.
In another embodiment, as shown in fig. 15, a syringe 400 is provided with an inner sleeve 106 having a luer connector 402 at its distal end. In other respects, the syringe may be substantially the same as the syringe 100 described above. This allows the syringe 400 to be connected to tubing set 404 to allow the drug to be delivered by, for example, an intravenous or intraosseous infusion device. The luer connector 402 may be a male luer connector for connection to a female luer fitting 406 of a tubing set. Alternatively, the luer connector 402 may be a female luer connector for connection to a male luer fitting. Syringe 400 may use a locking or sliding type LUER connection (e.g., LUER-LOK under the name of hecton-DickinsonTMAnd LUER-SLIPTMDown-market connectors) are attached to the tubing set 404.
In operation, the cap 103 is removed from the body 102 of the syringe 400. The luer fitting 406 is then attached to the luer connector 402. The drug may then be delivered through the tubing set 404 by translating the outer sleeve 104 relative to the inner sleeve 106. This causes the drug to be delivered through the luer connection, tubing set 404, and to the patient.
As shown in fig. 16, a handle 500 may be provided on the syringe 100, 200, 400. The handle 500 may be, for example, integrally formed on the outer sleeves 104, 204, or alternatively, the handle 500 may be a separate component, for example, a sleeve that slides over the outer sleeves 104, 204. The handle 500 may have any size. For example, the handle 500 may cover all of the outer sleeves 104, 204. Alternatively, the shank 500 may cover only a portion of the outer sleeve 104, 204. The handle 500 may be formed from any suitable material. For example, the handle 500 may be molded from santoprene (santoprene) or other elastomeric material. The materials may be selected to increase the ability to handle the syringe 100, 200, 400. The handle 500 may include structures or patterns to further increase the ability to handle the syringe 100, 200, 400. For example, the shank 500 may include raised diamonds or wires, similar to those used on diamond plates.
In embodiments where the handle 500 is a separate component that slides over the outer sleeves 104, 204, the handle 500 may have a closed proximal end. This may further seal the proximal end of the syringe 100, 200, 400 and prevent the ingress of foreign particles or fluids.
A handle, such as the one shown in fig. 16, may be particularly advantageous when the syringe is used by the military in a combat situation. In such situations, the syringe may need to be used in severe and humid conditions by the military, which often wears gloves. Thus, it may be difficult to securely grip the syringe. By providing a syringe with a handle that is easily grasped even in difficult conditions, the syringe may be more reliably used in these potentially life saving situations.
In another embodiment, a method of operating a syringe is provided. The method includes the step of placing a distal end of the inner sleeve against a target location. Force is applied to the outer sleeve by the syringe in place. Applying a force to the outer sleeve, (i) causing axial translation of the outer sleeve and the barrel relative to the inner sleeve, (ii) causing the needle of the barrel to extend from the distal end of the inner sleeve and into the target position, and (iii) contacting the barrel with the engagement feature of the inner sleeve. Subsequently, a continuous force is applied to the outer sleeve. Applying the continuous force to the outer sleeve causes translation of the plunger rod and seal within the barrel, thereby delivering the medicament. After delivery of the drug, the syringe is removed from the target site. A biasing member exerts a force on the inner sleeve to translate the inner sleeve in the distal direction relative to the outer sleeve to cover the needle of the syringe such that the inner sleeve is locked in place relative to the outer sleeve.
In another embodiment, a method of operating an injector with a syringe having a retractable needle is provided. The cap of the syringe is removed, wherein the removal of the cap also removes the needle cover of the barrel. The method further comprises the step of placing the distal end of the inner sleeve against the target location. Force is applied to the outer sleeve by the syringe in place. Applying a force to the outer sleeve, (i) causing axial translation of the outer sleeve and the barrel relative to the inner sleeve, (ii) causing the needle of the barrel to extend from the distal end of the inner sleeve and into the target position, and (iii) contacting the barrel with the engagement feature of the inner sleeve. Subsequently, a continuous force is applied to the outer sleeve. Applying the continuous force to the outer sleeve causes translation of the plunger rod and seal within the barrel, thereby delivering the medicament. After delivery of the medicament is complete, the needle is retracted into the barrel of the barrel.
In another embodiment, a method of delivering a drug intranasally using a syringe and nozzle is provided. The cap of the syringe is first removed. The nozzle is engaged with the syringe. Placing the tip of the nozzle within or adjacent to the patient's nostril. Translating an outer sleeve of the syringe toward the tip of the nozzle to expel the drug through the tip of the nozzle and to a patient.
In another embodiment, a method of delivering a drug intravenously or intraosseously using a syringe is provided. The cap of the syringe is first removed. The luer connector of the inner sleeve is connected to the luer fitting. Translating an outer sleeve of the syringe toward the luer fitting to deliver the drug through the luer connector, through a tubing set, and to a patient.
While the foregoing description and drawings represent the preferred or exemplary embodiments of the present invention, it will be understood that modifications and substitutions may be made therein without departing from the spirit and scope of the appended claims and the scope of equivalents. In particular, it will be clear to those skilled in the art that the present invention may be embodied in other forms, structures, arrangements, proportions, sizes, and with other elements, materials, and components, without departing from the spirit or essential characteristics thereof. Furthermore, numerous variations of the methods/processes described herein may be made without departing from the spirit of the invention. It will be further understood by those skilled in the art that the present invention may be used with many modifications of structure, arrangement, proportions, sizes, materials, and components, and otherwise, used in the practice of the invention which are particularly adapted to specific environments and operative requirements without departing from the principles of the present invention. The presently disclosed embodiments are therefore to be considered in all respects as illustrative and not restrictive, the scope of the invention being defined by the appended claims and equivalents thereof, and not limited to the foregoing description or embodiments. Rather, the appended claims should be construed broadly, to include other variants and embodiments of the invention which may be made by those skilled in the art without departing from the scope and range of equivalents of the invention. All patents and published patent applications identified herein are incorporated by reference in their entirety.

Claims (16)

1. A syringe for delivering a drug, comprising:
an outer sleeve defining a longitudinal axis, the outer sleeve including a raised border extending from an inner wall, wherein the raised border extends along a path having a longitudinal component and a circumferential component extending along a circumference of the outer sleeve;
an inner sleeve partially disposed within the outer sleeve; and
a syringe having a barrel, a needle mounted to a distal end of the barrel, a plunger rod and a seal slidably mounted in the barrel, wherein the plunger rod is engaged with the outer sleeve in a fixed spatial relationship such that the plunger rod and the outer sleeve translate as a unit throughout operation of the syringe;
wherein the outer sleeve is disposed and configured to axially translate relative to the inner sleeve from a first configuration in which the inner sleeve extends a first distance from the outer sleeve to a second configuration in which the inner sleeve extends a second distance from the outer sleeve that is less than the first distance, and further wherein in a third configuration the inner sleeve extends a third distance from the outer sleeve that is greater than the second distance and limits axial translation of the inner sleeve relative to the outer sleeve.
2. The syringe of claim 1, wherein the raised edging is at least partially disposed in a recess formed in the outer sleeve.
3. The syringe of claim 1, wherein the inner sleeve includes flexible arms extending parallel to the longitudinal axis, the flexible arms having protrusions extending radially outward from the inner sleeve to engage the raised edging.
4. The syringe of claim 3, wherein the protrusion travels along a first side of the raised edging as the outer sleeve translates from the first configuration to the second configuration, and wherein the protrusion travels along a second side of the raised edging as the outer sleeve translates from the second configuration to the third configuration.
5. The syringe of claim 4, wherein travel along the first side of the raised edging causes deflection of the flexible arm, and wherein when the outer sleeve reaches the second configuration, the protrusion disengages the raised edging and contacts an impact surface, thereby providing audible or tactile feedback to a user.
6. The syringe of claim 3, wherein the flexible arm is in an unstressed position when the outer sleeve is in the first configuration.
7. The syringe of claim 3, wherein in the third configuration, the protrusion is disposed between the raised edging and a locking member, thereby limiting relative translation of the inner sleeve and the outer sleeve.
8. The syringe of claim 1, wherein the inner sleeve defines a distal end and a proximal end, and wherein the inner sleeve includes at least one engagement member extending from an inner wall of the inner sleeve at a location intermediate the distal end and the proximal end.
9. The injector of claim 1, further comprising a cap and the syringe further comprises a needle cover, wherein the cap is configured to engage the needle cover such that removal of the cap from the injector removes the needle cover from the syringe.
10. The syringe of claim 1, further comprising a biasing member positioned proximally of the inner sleeve and configured to exert a force on the inner sleeve in a distal direction.
11. A syringe for delivering a drug, comprising:
an outer sleeve;
an inner sleeve partially disposed within the outer sleeve, the inner sleeve defining a chamber between distal and proximal ends of the inner sleeve and having an engagement member extending into the chamber at a location between the distal and proximal ends; and
a syringe having a barrel, a needle mounted to a distal end of the barrel, a plunger rod and a seal slidably mounted in the barrel, wherein the plunger rod is engaged with the outer sleeve in a fixed spatial relationship such that the plunger rod and the outer sleeve translate as a unit throughout operation of the syringe;
wherein the outer sleeve is disposed and configured to axially translate relative to the inner sleeve, and wherein in a first configuration the engagement means is spaced from the barrel of the syringe, and wherein in a second configuration the syringe contacts the engagement means such that continued axial translation of the outer sleeve causes translation of the plunger rod relative to the barrel to deliver the medicament through the needle.
12. The syringe of claim 11, wherein only a portion of the needle extends from the inner sleeve when the engagement means is in contact with the barrel of the barrel.
13. The injector of claim 11, wherein the translation of the syringe from the first configuration to the second configuration is caused by friction between the seal and the barrel.
14. The syringe of claim 11, wherein the engagement means is integrally formed with the inner sleeve.
15. The syringe of claim 11, wherein in the second configuration, the needle extends from the inner sleeve a sufficient distance for subcutaneous delivery.
16. A syringe for delivering a drug, comprising:
an outer sleeve defining a longitudinal axis;
an inner sleeve partially disposed within the outer sleeve, the inner sleeve defining a distal end and a proximal end, and wherein the inner sleeve includes at least one engagement member extending from an inner wall of the inner sleeve at a location intermediate the distal end and the proximal end; and
a syringe having a barrel, a needle mounted to a distal end of the barrel, a plunger rod and a seal slidably mounted in the barrel, wherein the plunger rod is engaged with the outer sleeve in a fixed spatial relationship such that the plunger rod and the outer sleeve translate as a unit throughout operation of the syringe;
wherein the outer sleeve is disposed and configured to axially translate relative to the inner sleeve from a first configuration in which the inner sleeve extends a first distance from the outer sleeve to a second configuration in which the inner sleeve extends a second distance from the outer sleeve that is less than the first distance, and further wherein in a third configuration the inner sleeve extends a third distance from the outer sleeve that is greater than the second distance and limits axial translation of the inner sleeve relative to the outer sleeve, and wherein in the second configuration the engagement means contacts the barrel such that continued axial translation of the outer sleeve causes translation of the plunger rod relative to the barrel to deliver medicament through the needle.
CN201780084896.8A 2016-12-27 2017-12-18 Device and method for injecting a drug Active CN110325231B (en)

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US11135371B2 (en) 2021-10-05
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US20190160228A1 (en) 2019-05-30
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US10232117B2 (en) 2019-03-19
JP2020503137A (en) 2020-01-30

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